Cleared Traditional

K861051 - ISOLIFE DISPENSING SYSTEM

K861051 is an FDA 510(k) clearance for ISOLIFE DISPENSING SYSTEM, manufactured by Navaco Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K861051 · Navaco Laboratories · Gastroenterology & Urology device
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Apr 1986
Decision
15d
Days
Class 2
Risk

K861051 is an FDA 510(k) clearance for the ISOLIFE DISPENSING SYSTEM. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Navaco Laboratories (Mcallen, US). The FDA issued a Cleared decision on April 3, 1986 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Navaco Laboratories devices

FDA 510(k) Submission Details - K861051

510(k) Number K861051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1986
Decision Date April 03, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K861051.
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
K861618 · Travenol Laboratories, S.A. · Jul 1986
ONE TIME ENTERAL FEEDING BAG
K860818 · Acme United Corp. · May 1986
SCLEROTHERAPY INJECTION CATHETER
K860991 · Endovations · May 1986
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
K860285 · Vygon Corp. · Feb 1986
ENTERAL FEEDING BAG
K854616 · Medovations, Inc. · Jan 1986
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986